Clinical Efficacy and Safety of Oral Qing-Dai in Patients with Ulcerative Colitis: A Single-Center Open-Label Prospective Study

Shinya Sugimoto, Makoto Naganuma, Hiroki Kiyohara, Mari Arai, Keiko Ono, Kiyoto Mori, Keiichiro Saigusa, Kosaku Nanki, Kozue Takeshita, Tatsuya Takeshita, Makoto Mutaguchi, Shinta Mizuno, Rieko Bessho, Yoshihiro Nakazato, Tadakazu Hisamatsu, Nagamu Inoue, Haruhiko Ogata, Yasushi Iwao, Takanori Kanai

Research output: Contribution to journalArticle

33 Citations (Scopus)

Abstract

Background/Aims: Chinese herbal medicine Qing-Dai (also known as indigo naturalis) has been used to treat various inflammatory conditions. However, not much has been studied about the use of oral Qing-Dai in the treatment for ulcerative colitis (UC) patients. Studies exploring alternative treatments for UC are of considerable interest. In this study, we aimed at prospectively evaluating the safety and efficacy of Qing-Dai for UC patients. Methods: The open-label, prospective pilot study was conducted at Keio University Hospital. A total of 20 patients with moderate UC activity were enrolled. Oral Qing-Dai in capsule form was taken twice a day (daily dose, 2 g) for 8 weeks. Results: At week 8, the rates of clinical response, clinical remission, and mucosal healing were 72, 33, and 61%, respectively. The clinical and endoscopic scores, CRP levels, and fecal occult blood results were also significantly improved. We observed 2 patients with mild liver dysfunction; 1 patient discontinued due to infectious colitis and 1 patient discontinued due to mild nausea. Conclusion: This is the first prospective study indicating that oral Qing-Dai is effective for inducing remission in patients with moderate UC activity and can be tolerated. Thus, Qing-Dai may be considered an alternative treatment for patients, although further investigation is warranted.

Original languageEnglish
Pages (from-to)193-201
Number of pages9
JournalDigestion
DOIs
Publication statusAccepted/In press - 2016 Mar 10

Fingerprint

Ulcerative Colitis
Prospective Studies
Safety
Indigo Carmine
Occult Blood
Qingdai compound
Herbal Medicine
Colitis
Nausea
Capsules
Liver Diseases
Therapeutics

Keywords

  • Aryl hydrocarbon receptor
  • Chinese herbal medicine
  • Colon
  • Indigo naturalis
  • Indole
  • Inflammatory bowel disease
  • Interleukin-22#
  • Qing-Dai
  • Ulcer healing
  • Ulcerative colitis

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Clinical Efficacy and Safety of Oral Qing-Dai in Patients with Ulcerative Colitis : A Single-Center Open-Label Prospective Study. / Sugimoto, Shinya; Naganuma, Makoto; Kiyohara, Hiroki; Arai, Mari; Ono, Keiko; Mori, Kiyoto; Saigusa, Keiichiro; Nanki, Kosaku; Takeshita, Kozue; Takeshita, Tatsuya; Mutaguchi, Makoto; Mizuno, Shinta; Bessho, Rieko; Nakazato, Yoshihiro; Hisamatsu, Tadakazu; Inoue, Nagamu; Ogata, Haruhiko; Iwao, Yasushi; Kanai, Takanori.

In: Digestion, 10.03.2016, p. 193-201.

Research output: Contribution to journalArticle

Sugimoto, Shinya ; Naganuma, Makoto ; Kiyohara, Hiroki ; Arai, Mari ; Ono, Keiko ; Mori, Kiyoto ; Saigusa, Keiichiro ; Nanki, Kosaku ; Takeshita, Kozue ; Takeshita, Tatsuya ; Mutaguchi, Makoto ; Mizuno, Shinta ; Bessho, Rieko ; Nakazato, Yoshihiro ; Hisamatsu, Tadakazu ; Inoue, Nagamu ; Ogata, Haruhiko ; Iwao, Yasushi ; Kanai, Takanori. / Clinical Efficacy and Safety of Oral Qing-Dai in Patients with Ulcerative Colitis : A Single-Center Open-Label Prospective Study. In: Digestion. 2016 ; pp. 193-201.
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AU - Kiyohara, Hiroki

AU - Arai, Mari

AU - Ono, Keiko

AU - Mori, Kiyoto

AU - Saigusa, Keiichiro

AU - Nanki, Kosaku

AU - Takeshita, Kozue

AU - Takeshita, Tatsuya

AU - Mutaguchi, Makoto

AU - Mizuno, Shinta

AU - Bessho, Rieko

AU - Nakazato, Yoshihiro

AU - Hisamatsu, Tadakazu

AU - Inoue, Nagamu

AU - Ogata, Haruhiko

AU - Iwao, Yasushi

AU - Kanai, Takanori

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AB - Background/Aims: Chinese herbal medicine Qing-Dai (also known as indigo naturalis) has been used to treat various inflammatory conditions. However, not much has been studied about the use of oral Qing-Dai in the treatment for ulcerative colitis (UC) patients. Studies exploring alternative treatments for UC are of considerable interest. In this study, we aimed at prospectively evaluating the safety and efficacy of Qing-Dai for UC patients. Methods: The open-label, prospective pilot study was conducted at Keio University Hospital. A total of 20 patients with moderate UC activity were enrolled. Oral Qing-Dai in capsule form was taken twice a day (daily dose, 2 g) for 8 weeks. Results: At week 8, the rates of clinical response, clinical remission, and mucosal healing were 72, 33, and 61%, respectively. The clinical and endoscopic scores, CRP levels, and fecal occult blood results were also significantly improved. We observed 2 patients with mild liver dysfunction; 1 patient discontinued due to infectious colitis and 1 patient discontinued due to mild nausea. Conclusion: This is the first prospective study indicating that oral Qing-Dai is effective for inducing remission in patients with moderate UC activity and can be tolerated. Thus, Qing-Dai may be considered an alternative treatment for patients, although further investigation is warranted.

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